The present invention relates, in general, to embodiments of a prosthetic anatomical device having a particularly designed sewing cuff. Methods and structures for securing the cuff to the prosthetic anatomical device, such that rotational stability is achieved therebetween, are also disclosed.
Typically, prosthetic anatomical devices, such as, for example, annuloplasty prostheses, include a core member that in some cases may be surrounded by a soft fabric cover. The core member is often substantially rigid or at least semi-rigid and is not penetrable by a suture needle and suture material. The fabric cover may be designed to cushion the prosthesis, and possibly also to promote tissue in-growth into the prosthesis to help integrate the prosthesis into the patient's body. It is often desired to secure the prosthesis to the patient by passing one or more suture needles and suture material through the fabric cover and adjacent tissue. Tightness and/or thinness of the fabric cover may, however, make this difficult to do. For example, a tight and/or thin fabric cover may result in a surgeon accidentally threading a needle through the core member, which can result in damage to the ring and/or needle. What's more, even if the surgeon is successful in getting proper engagement between the needle and the fabric cover, the amount of fabric caught may be less than would be desirable for good tissue healing and/or over-growth.
To facilitate suturing an annuloplasty prosthesis to a patient, a sewing cuff may be provided with the prosthesis. Examples of a sewing cuff(s) used for this purpose are found in at least U.S. Pat. No. 7,938,856 to Lim et al. (“Lim”), which is incorporated by reference herein in its entirety. These sewing cuffs are generally extensions of the fabric cover that is provided around the core of the prosthesis, which supplies a surgeon with an area to anchor the annuloplasty prosthesis and allow for tissue in-growth at the surgical site. Further, in the case of Lim, since the cuff typically extends from the core member, the surgeon is provided with an area to secure the ring to the patient, which is not adjacent to or near the core member. As such, the surgeon is less prone to inadvertently contacting the core member while suturing the cuff to the patient. In addition, the cuff also allows a surgeon the ability to position and hold the annuloplasty ring in a desired orientation within the valve annulus (e.g., by suturing the cuff and therefore the prosthesis to the patient in a particular orientation).
An alternate version sewing cuff is shown in FIG. 6 in which the cuff 340 is formed by wrapping a cover 330 about a core 320 of prosthesis 310. Here, the portion of cover 330 forming cuff 340 is folded over on itself, and is generally situated against or close to the core 320 of prosthesis 310, as opposed to extending outward therefrom. Prosthesis 310, with this specifically designed cover 330 forming cuff 340, is currently sold by St. Jude Medical® under the trade name “Rigid Saddle Ring with EZ Suture™ Cuff.”
Annuloplasty prostheses with a cuff, as described, can experience rotational instability relative to the core of the prosthesis. Stated differently, in some cases, the fabric forming the cuff is able to rotate relative to the prosthesis core, causing the desired orientation of the prosthesis to change. This may have the effect of changing the shape of the opening created by the prosthesis, as many prostheses have a D-shaped profile or, in some cases, a C-shaped profile. Alternatively, such rotational instability may make it more difficult for the surgeon to suture the prosthesis to a patient, which is primarily due to unwanted movement of the fabric cover with respect to the core.